This invention relates to a two-piece ostomy appliance having a faceplate component and a pouch component wherein the faceplate has a protective collar for shielding surrounding edges of the water-soluble layer (or layers) of the pouch from fluids which pass through the side opening in the pouch wall.
Two-piece ostomy appliances having faceplate components and pouch components are well known in the art. For examples of such devices, reference may be had to co-owned U.S. Pat. Nos. 4,419,100, 4,610,676 and 4,610,677.
Recently it has been considered desirable to provide flushable ostomy pouches that may be discarded into toilet bowls or water closets. The walls or panels of such a pouch are typically composed of at least two layers, specifically, a tough flexible, but water-soluble or water-dispersible primary layer which gives the pouch its structural integrity and a thin, water-insoluble inner layer which lines the inside of the pouch and prevents the pouch's contents from contacting and dissolving the primary layer when the pouch is worn. Although the primary layer gives the pouch its strength, once the pouch is discarded into the bowl of a flush toilet, the primary layer, being exposed to water in the bowl, quickly dissolves allowing the weaker interior layer to disintegrate and disperse by the turbulence of water when the toilet is flushed.
A characteristic shortcoming of such a system is that either an edge of the primary water-soluble layer is left exposed about the stoma-receiving side opening of the pouch where it may be contacted by aqueous body fluids discharged into the pouch that could result in premature disintegration of the pouch while it is being worn, or some additional means or manufacturing technique must be utilized to protect such edge from contact with effluent. The first of these approaches assumes that the risk of pouch failure may be minimized by limiting the length of time a given pouch is worn (see U.S. Pat. No. 4,772,279), whereas the second approach necessarily increases the complexity and cost of pouch construction and manufacture and may also have the undesirable result of weakening the structure of the pouch in the region of its stoma-receiving opening. Examples of this second approach are found in U.S. Pat. Nos. 4,917,689 (an additional ring or flange is secured to the inner layer and extends through the stoma-receiving opening of the pouch to cover the edge of the dissolvable primary layer), 4,772,279 (the background portion of this patent discloses an inner layer that projects beyond the edge of the primary layer and is sealed to an annular outer member to conceal the edge of the primary layer), and UK patent 2,083,762B (a gum ring is applied to the pouch to cover the annular edge of the primary layer). In these specific examples, the techniques involve modifying the construction of the pouches themselves to avoid or reduce the risk of exposing the edge of primary layers to contact with fluids passing though the stoma-receiving openings. Such expedients, in addition to the disadvantages of complexity and expense already mentioned, may also have the undesirable effect of reducing the flushability of the pouches by adding protective elements that may be substantially insoluble in the water of a toilet bowl or sewage system.
The present invention addresses the above problems by providing a two-piece appliance in which the means for protecting the annular edge of the primary layer is provided not by the pouch itself but by the faceplate component. Specifically, the separate faceplate component is equipped with an attachment ring having a protective annular collar which is inserted into the stoma-receiving opening (or side opening) of the pouch component when the parts are joined together. By providing the faceplate component with means for shielding the exposed edge of the water-soluble or dispersible primary layer of the pouch component, as well as the edge of any other water-soluble element provided by the pouch about its stoma-receiving opening, the pouch component may be easily and relatively inexpensively manufactured, since the pouch component does not require its own protective flange or gum ring permanently affixed about its stoma-receiving opening and does not necessitate special manufacturing steps such as the removal or concealment of an edge portion of the pouch's primary or exterior layer during manufacture. In a preferred embodiment, the pouch component of the present invention is provided with a thin, flexible, adhesive-coated mounting ring, ideally formed of water-soluble polymeric material, exteriorly affixed to the pouch about its stoma-receiving opening. After removal of a release sheet that covers the adhesive coating of the mounting ring, the axially-extending collar of the faceplate attachment ring is inserted into the opening of the pouch. The collar therefore serves as a locating element to guide proper assembly of the parts in addition to performing its primary function of shielding the edges of the water-soluble layer(s) of the pouch when the components are sealed together.
Other features, advantages, and objects of the invention will become apparent from the specification and drawings.